What is wrong with the Tobacco Products Directive for vapour products?

Provisions for vapour products were designed in a political process in haste, in secret, without consultation, with no impact assessment and in the face of opposing scientific advice – and it shows

The European Union directive governing e-cigarette regulation is a catalogue of poorly designed, disproportionate and discriminatory measures that will achieve nothing useful but do a great deal of harm. Let’s review the main issues:

From 20 May 2016, e-cigarettes and other nicotine vapour products will be regulated in Europe under Article 20 of the Tobacco Products Directive (2014/40/EU). The main issues with the directive are that in several areas harmful unintended consequences (usually meaning more smoking) are likely to far exceed any intended benefits, where these can be identified at all. The public health community has been very slow to understand how ‘tough’ regulation of e-cigarette and vaping easily amounts to regulatory protection of the cigarette trade – discussed here: Turning the tables on public health – let’s talk about the risks *they* create and here Big Tobacco’s Little Helpers. What does tough regulation of harm reduction actually mean? The directive provides a number of specific cases of this problem – costs, burdens or restrictions with little benefit and huge unintended consequences that reduce the appeal of e-cigarettes relative to cigarettes. Main examples:

A ban on almost all advertising sponsorship and promotion of e-cigarettes.The anti-competitive e-cigarette advertising ban protects the incumbent cigarette trade from a disruptive challenger and is unjustified in a directive with a single market legal base, and disproportionate relative to tobacco. Most tobacco advertising is banned in the EU, but that’s because tobacco kills 700,000 per year. In contrast, vaping is likely to reduce premature deaths. Banning advertising hampers the development of trusted brands, communication of innovation and the aspirational messages that help new products succeed. Limitations on advertising similar to those applied to alcohol are justified – as implemented by the UK Committee on Advertising Practice [broadcast / non-broadcast codes for e-cigarettes] but the directive goes far beyond these.

Limiting the strength of nicotine liquids to 20mg/ml (2%) nicotine. Approximately 25-30% of consumers use liquids stronger than this. There are four downsides to this limit: (1) stronger liquids may be more important for more heavily dependent smokers; (2) they are important for smokers in the process of switching – new users may not have acquired the skill or familiarity to find vaping a satisfactory alternative to smoking in the early days – the strength limit will cause more to relapse; (3) in a market that values miniaturisation it may be a barrier to innovation – allowing more nicotine to be kept in a smaller volume may be important in future product design; (4) for those users who would prefer stronger e-liquids, it will mean they will need to inhale more vapour to get the nicotine they want – if there are any hazardous substances in vapour, this policy will increase exposure (hat tip). No argument exists for actually doing this. If the concern is poisoning then child-resistant containers are the answer.

Limiting size of e-juice containers to 10ml and tanks or cartridges to 2ml. No purpose to this other than bureaucratic harassment – though it is probably based on wild misunderstandings of nicotine toxicity and overstated LD50 (lethal dose). It actually means more fiddling about, more frequent refilling, more spillage possibilities more chance of running out, high costs for users etc. Again, we solve problems of hazardous liquids, like bleach for example, not by insisting that they are held in thimble sized containers, but by having child resistant packaging – as in ISO8317. This issue is compounded by the limit on strength – how do smaller tanks of weaker liquid help in the competition for smokers?

Excessive warnings. By design the mandatory warnings required will be unmistakably similar to those used on cigarettes – bold black and white cover 30% or more of the main pack surfaces – yet there is nothing like equivalent risk. The only warning needed is reference to nicotine along with an age restriction 18+ and keep out of children’s reach – just like they have on off-the-shelf medications.In addition each pack will need to contain a leaflet – even though nothing similar is required for cigarettes. As with marketing, alcohol warnings would offer a proportionate benchmark.

Notification regime.Before a product can be put on the market a dossier of information has to be provided to the Commission followed by a 6 month wait. It is a notification regime – if the information required is provided the product can be placed on the market. There’s devilment in this – the Commission has delegated authority to define what information is required. It could require extensive testing of thousands of product combinations in many different operating conditions. None of this is required to place a cigarette on the market – this needs only minimal testing of crude metrics (tar, nicotine and carbon monoxide) with long established protocols. At the time of writing, the e-cigarette notification regime is under discussion: see draft data dictionary. And it is very demanding, though fortunately it does not go as far as requiring pharmacokinetic studies. However, it does introduce numerous wasteful burdens that have no real purpose – like a lot of EU regulation it appears indifferent to costs and burdens, yet these will break some of the smaller, more agile companies. For example:

Measurement of TSNAs measurements in aerosol is pointless given that pharma grade nicotine is specified elsewhere. The same applies for ethylene glycol and DEG.

Measurement of aerosol particulate matter is irrelevant: what are the implications? It’s just make-work.

The EU admits their inability to develop a standard testing protocol, so they just specify any old scheme and then require them to redo it once the Commission does know what it is doing: “In the absence of agreed standards/protocols, emissions measuring should be performed for both the medium range wattage and the maximum wattage. All other settings (i.e. airflow, puffing etc.) are to be described within the next item, Item #6.31 (methods). After the unified standards/protocols for emission measuring have been developed, the stakeholders will have to repeat the tests using the standardised protocol…“

They specify testing for atomisers with the “most commonly sold liquid and battery”. For battery testing, use the most commonly sold atomiser and liquid. For liquid, the most commonly sold atomiser and battery. It should be obvious that these ‘most commonly sold’ products are different in all markets and change all the time. So what use will the data be?

Leak free filling.The Commission, though not a manufacturer or designer of anything, is to specify a leak free filling mechanism. Depending what these civil servants come up with, it is possible that this will create a de facto ban on ‘tank’ products – requiring a cartridge approach (supporting the razor-blade business model favoured by some vendors). This being the most individually personalisable and most likely to function as a successful alternative to smoking. This provides a ‘solution’ to a non-problem or one that could be left to the market to address for those who want it. This provision could also make it impossible to have rebuildable or replaceable coils – effectively mandating disposable products. However, the technical standard will not be settled until 2nd quarter 2016, even though the directive applies from 20 May 2016 – so some fudge will be needed in the short term (see Peter Becket’s comment below). Documentation on this issue: Commission’s Letter (PDF); Consultant’s questionnaire (Word).

Medicine regulation mandatory. Some member states, for example Sweden, will interpret the directive as allowing them to require all e-cigarette to be regulated as medicines. This regulatory regime applies the restrictive, costly and immensely burdensome medicines regime to what is in reality a fast moving consumer good. The will create very high barriers to entry and dramatically contract the range of products on the market, favour the high volume commodity products, and ensure that only the largest players (i.e. major tobacco companies) can participate. It will destroy the industry’s model of innovation in which new products are coming into the market every six months – nothing like the pharma model, which relies on a stable patent-protected market. It was a huge fight to persuade the European Parliament to reject mandatory medicines regulation – see arguments here and here – why has it crept back in by stealth? The language was intended to recognise a ‘twin track’, in which a manufacture could seek a marketing authorisation if they wished to make a therapeutic claim.

Power to ban certain types of vapour product. Para 11 of Article 20 was introduced to appease member states who wished to ban refillable tank systems. The language has been made reasonable – there has to be clear danger to health and a ban has to be a proportionate and justified response – but the intention is the troubling part of this.

Bans and other extreme measures. Even though the directive is supposed to approximate laws with a view to developing the single market it contains at Article 24 a general provision allowing member states to go further than the directive and to impose bans. This provision allows member states to contemplate ‘plain packaging’ for example. This article could be used by the more zealous member states to ban flavours, impose plain packaging etc.

De facto ban on tanks/mods? Does the combination of several provisions create a de facto ban on tanks and mods, without actually specifying it? In other words is the regulation geared to work with, and only with, high volume commoditised products using sealed units or cartridges? Several measures may simultaneously combine to lead to this: the burdensome notification and testing regime; the leak-free filling mechanism; tamper-proofing; limits on tank size; member state unilateral action. The latest data from ASH (UK) show these products to be now the most popular (most often used by 66% of users in 2015, up from 40% in 2014); that most users have migrated to them from lower specification devices (only 28% start with these devices but by 2015 they were most popular for 66% of users). Those figures show the market ‘voting’ for the higher spec tanks and mods products.

Report on potential health risks to public health from refillable electronic cigarettes – due 2Q 2016. By PRECISE consortium.

Technical standards for the refill mechanism for electronic cigarettes – due by 2Q 2016. By PRECISE consortium.

Reporting format for electronic cigarettes – due by 4Q 2015. By EUREST consortium.

Note that PRECISE and EUREST are led by Biomedical Research Foundation,Academy of Athens (BRFAA).

Bad process: the directive is as bad as it is mainly because the process of making it breached most principles of good policy-making. A full account of the shoddy, secretive and unaccountable process is set out in my complaint to the EU Ombudsman (background), which she declined to consider.

Legal challenge: Totally Wicked is challenging Article in the Court of Justice of the European Union. See my guide to the case here, and if you want to support Totally Wicked’s case, do it here.

This is wrong on so many levels.
1. Yes testing of juice is good but making the bottles only 10ml totally pointless.
2. Making tanks only 2ml this is also pointless as people will just have to fill up more and buy more juice.
3.The main problem here is the term e-cig instead of using a correct term like vaporizer. E-cig may have been ok for the devices that actually looked like cigs but not for any other device. The term e-cig makes it sound bad from the start.
4. Lets face it TPD was brought in because people are switching to vaping for health reasons and the tax that was being made from tobacco is being lost and must be recovered somehow.
5. Many people will now stay smoking tobacco without knowing how much vaping could save them in their health and wallet because of TPD.
6.TPD will have cost many people to get into financial difficulties because of being a business selling vaping products who are stuck with products they cannot legally sell.

Well on 7th Feb an independent study has shown that for people who use eliquids and vape, it’s far better for your health with 97% less cancer causing toxins in the body after only 6 months!. Get yourself down to a vape shop I say and save your health.

[…] finally being passed through the European Parliament. Constant revisions, including the addition of unjustified new regulations on e-cigarettes with little to no consultation with the electronic cigarette industry made it into […]

[…] regulations from someone with more first hand experience with them, please give the article from Clive Bates a read. He does an excellent job of breaking down examples of the effect the directive will […]

[…] regulations, 2016). As regular readers will know I think Article 20 dealing with e-cigarettes is useless and does little but protects the cigarette trade. I can report that the Impact Assessment […]

[…] upcoming CLTANK form Kanger looks to be one of the larger manufacturers first attempt at a TPD (Tobacco Product Directive) compliant tank, which makes it very interesting indeed. Why is this so interesting you may say! […]

[…] hard to keep up with the public health madness in Europe. Not content with creating the worst EU Directive ever made, laden with unintended consequences, many member states are now working hard on compounding their […]

[…] hard to keep up with the public health madness in Europe. Not content with creating the worst EU Directive ever made, laden with unintended consequences, many member states are now working hard on compounding their […]

Theres’s not all-encompassing resource for keeping track of all the hashtags out there but a few services, like Statigram, keep the most recent contest hashtags at the ready for you to access.
I grew up wondering what Jesus did on Monday evenings.
Ever since, the application has gained popularity in a manner not similar to My – Space.

[…] Bates writes frequent articles on the TPD and has discussed its failings on the following link What’s wrong with the tobacco products directive for vapour products. In his recent article Clive Bates discusses where we are now with the TPD, critically evaluating […]

Article 20 of the TPD is there to protect the tobacco industry. The provisions of the TPD are phrased in such a nebulous manner so as to make compliance both difficult and prohibitively expensive. This will drive small e-liquid companies out of business and redirect the revenues into the coffers of big tobacco companies.

I know that a LOT of people are fighting for us, behind the scenes,
so please don’t for one minute think that I am being critical to anyone
and how they are fighting this.
That said, I do see a lot of people fighting this good fight,
however, we NEED to do MORE. A lot of what is being done to fight this
is calling Reps, Signing Petitions, and writing to our politicians.

This is 2015, we need to FIGHT this like it is 2015.

WE need to Twitter Bomb the EU and American Politicians. NOT just once, but, over and OVER and OVER again… WE need to take to Social media like this is our last day on earth. WE need to do this in such a manner, as to make a HUGE splash, and one person can not do this. This needs
100’s of people from around the globe, EVERY single HOUR, we need to Tweet and Facebook, etc.. etc.. KEY Figures in this fight.
My suggestion is Tweeting President Obama, Hillary, Bernie, Trump, Rand Paul, Ben Carson… EVERY hour.. If we got 100 people to Tweet them, EVERY hour for as long as possible.. then, he would see that there are a LOT of people who stand to lose a lot in this fight, same with The EU Parliament… also, the media outlets…. We need to Tweet and Facebook the heck out of them, so that they can NO LONGER ignore us.
WE need to organize this in such a way, that they get SICK of seeing our names on their Twitter page.

Then, I think we need to find some people who can travel to Brussels and we need to stand IN FRONT of EU Parliament and protest these new laws that are coming into effect in May 2016..
I don’t mean ONE day either… I mean for DAYS… UNTIL they can NO longer ignore us. This should also be done in Washington DC.
We need to get their attention and let them know, that these laws they are enacting around us, are HARMFUL. What we need is to get a LOT of attention, it is just too easy to ignore us as it is, right now.

[…] As the revised Tobacco Products Directive (TPD) draws closer to implementation by 20 May 2016, many are wondering what can be done about this dire piece of legislation – at least as it applies to ‘tobacco harm reduction’: e-cigarettes (Article 20), novel tobacco products (Article 19) and snus (Article 17). I have discussed its multiple failings here: What’s wrong with the tobacco products directive for vapour products. […]

Louise – it is a real tragedy and damning indictment that we are essentially in damage limitation exercise when so much time and money has been wasted in Brussels and Strasbourg creating this dreadful botch job. One wonders why civil servants think they should be paid for this.

[…] in striking it down. Nevertheless, I would like MHRA to approach this pragmatically, and recognise the many deficiencies in Article 20 of the Directive. The government will always uphold the law, but I would like MHRA to exploit the flexibilities […]

[…] directive, the Tobacco Products Directive has been passed comes into effect in May 2016 – this is poorly designed and excessive regulation but is simply not correct to say to the media that these products are […]

In recent months as both high performing tanks and batteries have become more common the testing problem becomes more obvious. By using the most common battery or most common tank to test with, it will not be possible to even fire many combinations that will create. Even if you could get a sub ohm tank to work on an EGO battery, the battery would be unable to deliver enough power to vaporise as designed. Likewise, an EVOD tank on a 150W box mod, will probably melt at the full power specified for testing.
As components become more advanced they need to be matched with suitable partners. You would get into trouble requiring Ferrari to test its tyres on a Micra, or expect Robin reliant brakes to stop you at 150Mph.
Its yet another example of a mind-set which cant grasp that ecigs are thousands of things, will millions of combinations.

Yes Mark. But that is the whole point of TPD/20: to eliminate anything useful, efficient and affordable; and to allow only the most basic and inefficient of devices and refills; and to give the market to the cigarette industry, so that it can be taxed and regulated out of contention.

The purpose of the TPD is to protect national exchequers, to protect pharmaceutical industry receipts from disease treatments, and to allow ecigs to be pigeon-holed with smoking so that vaping can be gradually eliminated. The cigarette trade will assist with this as it doesn’t want any real threat to cigarette sales. In fact no one wants any threat to cigarette sales, or TPD/20 wouldn’t exist.

Excellent as always.Was just wondering whether a comparison with the requirements of Art19 “Notification of novel tobacco products” would help emphasise the irrationality of Art20.I assume Philip Morris’s heat-not-burn device will be regulated under Art19?

There is one further problem with the 20mg/ml limit: nicotine is dosed on demand, so it will not reduce the amount of nicotine consumed but it will increase the amount of juice that must be consumed in order to obtain sufficient nicotine, exposing people to more risk even if it does not result in them returning to smoking. This measure is particularly illogical given that we know so much more about the (negligible) risks of nicotine than we do the other ingredients, especially flavours.

Good point Jo. Given that strengths above 20mg are deemed safe if classified as medicines, the only possible reason for the inclusion of this is to make vaping more inconvenient and less effective, in the hope that smokers will turn to pharmaceutical products.

There is a nasty catch on the implementation dates and leak free refilling. The Directive requires the Commission to bring forward an implementing act on technical specifications for a refill mechanism to prevent leakage while refilling (despite there not being a single reported adverse event related to the refilling of a tank). According to the implementation plan, this is not foreseen until Q2 of 2016. Which is the same quarter as the effective date.

Suppose the technical specifications entail substantial redesign of the product, but the Directive becomes effective before operators have the opportunity to undertake that redesign. What happens then? There will be nothing compliant on the market before 20 May 2016 because no one will have been told what compliant actually means before that date. So there will not be any product benefitting from the “grandfather date”. Yet, new stuff needs to be notified six months in advance. Taking into account the product development cycle, there is a serious risk of refillable devices being removed by stealth before compliant products have been designed, notified and placed on the market.

The obvious answer is the simplest one. Make sure the nozzle of the bottle fits inside the atomiser. Let us hope common sense prevails here…

I fail to see what is wrong with the EU directive. It will do precisely what it is designed to do:
– Protect tobacco tax revenues
– Protect favoured transnational industries (the pharmaceutical and tobacco industries)
– Protect governments in the EU socialised states from the vast expense of people living longer (the backend savings probably equal the frontend earnings on tax revenue)
– Protect the beneficial and stabilising effects of the smoking economy
– Prevent an economic timebomb caused by the removal of a $1 trillion-plus sub-economy that contributes significantly both to government exchequers and to stability

Of course, if the health of the public or human rights or the right of the individual to not be forced to smoke are your concern, then the TPD is not optimal. But please remember that the EU is not there to protect the individual, it is there to protect governments and transnationals from the unforeseeable and problematic effects of democracy.

We should all welcome the stability and safety the EU provides, for the greater good.

I started on 24mg liquid but didn’t stop dual use until 5 months later when I mixed by own 36mg liquid and used an advanced electrofag. I was a very heavy smoker for many years. I am now down to 12mg liquid after 9 months smoking cessation.

I had a very scary and enlightening experience yesterday. When Clive wrote here previously that there was a risk that vapers would return to smoking I thought very smugly “Well I wouldn’t”. Yesterday I forgot to take my electrofag with me when I went out and after 4 hours, despite having nicotine chewing gum with me, I bought a packet of cigarettes. I still don’t understand why and my only explanation is that tobacco has such a strong hold on me I look for any opportunity to indulge, despite the fact that they now taste foul. If I had been able to buy even a cigalike with nicotine I would have chosen that. I live in Australia of course.

Advertising: As we’ve seen in the UK even with the CAP code in place, many TV ads are being pulled due to “perceptions” of glamourising or sexualising smoking. Whilst not directly a part of the TPD, the CAP needs to be refined or maybe have some kind of threshold for perceptions (difficult to quantify). But the TPD goes far beyond this by restricting it to only “trade professionals” so retailers can’t advertise (the way I read it). Freedom of communication is key with some oversight needed to make sure that vendors and retailers don’t go too far.

Limiting Strengths: It would seem that by implementing the 20mg/ml limit they are intentionally aiming the higher strengths (initial switchers) at *medical intervention* (effectively) which is plain wrong. Maybe allow SSS to offer 20mg/ml + for new switchers rather than medicinal routes. This would allow monitoring of the services and give them a little ammunition for the “Endgame” as they like to call it.

Refill & Container Limits: Requiring a limit on the size of refills is going to be cost prohibitive for many users and for some vendors (at least to start with). Most vapers I know buy larger refills (15, 30, 50 or even 100ml bottles). This is one of the key reasons why vaping is substantially more cost effective for the consumer as a larger bottle can last a significant amount of time. For the devices (read Tanks), reducing capcity or volume makes no sense given the requirements for “leak free” and “tamper proof”. More frequent refills only serves to nullify those two points. This point, to me, only allows the larger (Tobacco sponsored) vendors more room to make money under the directive as they can “stamp out” devices at far less cost.

Warnings: The only warning needed is reference to Nicotine along with the obvious 18+ and keep out of childrens reach – just like they have on off-the-shelf medications. There does not need to be over-exaggerated warnings of “harms” that have not been proven. The least that should be done is what is already being done by most juice manufacturers, but maybe a compromise would be one of the “adivce leaflets” included with each bottle of juice.

Notification regime: Most of this is unwarranted as there is no current specifications in place for the actual testing of liquids. For the devices themselves, simple CE testing should suffice.

Leak Free Filling: This obviously precludes any system available on the market today, meaning that under the Directive only closed, non-refillable cartridges or tanks can be made available. Even petrol doesn’t come under this much scrutiny for refill. Leak free filling is a myth under any circumstances.

Bans: The trouble with the “certain types of vapor product” ban is ideology rather than factual. There would need to be consistent identification of “dangers and harms” in order for this to be a valid proposition, which doesn’t exist. Based on current evidence (and I mean ALL evidence) there doesn’t appear to be any consistent identification of harms or dangers.

Banning in public places should (imo) be restricted to municpal properties only if public bans is the route they wish to take, whilst businesses should be given clear and concise advice on the subject, however most bars/clubs/restaurants will most likely ban use anyway. Compromise there would be dedicated inside areas for use.

Until such time that flavours are proven beyond doubt (consistent identification of harm) that they cause harms, flavour bans are unjustifiable in the face of the evidence gathered that flavours are a key reason why people are switching to vapor products and plain packaging, which hasn’t worked for tobacco should not be considered simply for the reasoning of illicit material.

One of my main concerns with the whole idea of TPD Art 20, apart from the stated, is that it is the beginning of a slippery slope – who thinks this will be the end of it? It’s 20mg and 10ml in 2016, will it be 2mg in 2020, as has been already proposed during the process?

The TPD is the tobacco products directive and vaping has nothing to do with tobacco. It doesn’t belong there at all. I feel the TPD is actually a trojan horse. Members of the EUP would not enact a ban on vaping on its own, only due to the piggy backing on top of tobacco regulation was it allowed through.

According to ASH’s recent release.. • In 2014 41% of current vapers used ‘tank’ models while 55% used ‘cig-a-like’ devices
• In 2015 ‘tank’ models were the most popular product among current vapers with 66% using them while only 32% use ‘cig-a-like’ devices.
So, if the TPD goes through, as is, that could spell disaster for public health.
It’s about time the media WOKE UP!!

‘The European Union directive governing e-cigarette regulation is a catalogue of poorly designed, disproportionate and discriminatory measures that will achieve nothing useful but do a great deal of harm.’

That sums it sum very well.

And over the last year or so, a lot of harm has also been done by irresponsible journalism (of appalling quality), fed by statements by various public health ‘activists’, which has given the impression that vaping is as risky as burnt tobacco or only marginally less risky. Based on conversations with several smokers, my impression is that many have been deterred from considering vaping as a result.

I think we still have to see what consistent dose means in implementation practice: if it means within and between batches the product performs consistently, then that’s not too bad. If it means consistent dose in the sense of a drug delivery device metering out a fixed amount of nicotine, then obviously that is a huge consumer detriment – given the user always controls the nicotine ‘dose’.